Roche: FDA grants Priority Review for Gazyva/Gazyvaro (obinutuzumab) in primary membranous nephropathy
- FDA granted Priority Review to Roche’s supplemental BLA for obinutuzumab in primary membranous nephropathy based on phase III MAJESTY data.
- MAJESTY met its primary endpoint: 36.9% complete remission at 104 weeks with obinutuzumab versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001).
- The trial enrolled 142 adults randomized 1:1; obinutuzumab was also superior on key secondary endpoints and showed no new safety signals compared with its known profile.
- FDA had already granted Breakthrough Therapy Designation; a decision is expected by November 2026, and data are being submitted to other regulators including the EMA.
Regulatory status
The FDA has granted Priority Review to Roche’s supplemental Biologics License Application for Gazyva/Gazyvaro (obinutuzumab) in primary membranous nephropathy (pMN). The agency previously granted Breakthrough Therapy Designation for this indication and is expected to render a decision by November 2026. This follows a separate Priority Review granted in May 2026 for idiopathic nephrotic syndrome. Data from MAJESTY are also being submitted to other global health authorities, including the European Medicines Agency.
MAJESTY trial results
MAJESTY (phase III, randomized, open‑label, multicentre, N=142, 1:1 randomization) met its primary endpoint: 36.9% of adults treated with obinutuzumab achieved complete remission at two years (104 weeks) versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001). Key secondary endpoints—overall remission at week 104 and complete remission at week 76—also favored obinutuzumab. Safety was consistent with the established profile of the drug and no new safety signals were identified. The data were presented at the 63rd ERA Congress in June 2026 and published in the New England Journal of Medicine.
Clinical context
Primary membranous nephropathy is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; untreated, up to 30% of patients may progress to kidney failure over 10 years. Achieving complete remission is the key therapeutic aim to preserve kidney function and reduce long‑term complications. The condition has an estimated incidence of 1.2 per 100,000 people per year in the United States.
Programme implications and next steps
MAJESTY is the fourth positive phase III for obinutuzumab in immune‑mediated diseases following trials in lupus nephritis, systemic lupus erythematosus and idiopathic nephrotic syndrome. Roche is advancing regulatory filings and submissions internationally as the FDA review proceeds.
Source: Roche